Science in the Age of Trump

By DAVID SHAYWITZ, MD

As Donald Trump seeks to build his administration, he will likely struggle with creating a science infrastructure, given his estrangement from the nation’s scientific community.

The distance between Trump and scientists seems to reflect mutual disdain. Trump famously trusts his gut over more data-driven methods. Trump’s success, against most expectations, can be read as a triumph of instinct over science, or at least to reveal the perils of data-driven overconfidence. Trump’s apparent intention to appoint a climate-change skeptic to lead the environmental protection agency suggests to many a disregard for the vast weight of scientific data here, while his comments about vaccinations during one of the Republican debates were charitably described by Steven Salzberg as “wildly inaccurate” and “thoroughly discredited.”

For their part, most scientists take a very dim view of Trump: Science prides itself on being inclusive, international, objective and collaborative–not generally the first adjectives used to describe Trump. (Whether science in practice lives up to these ideals is another question.) Add to this Trump-specific distaste the left-leaning bias of universities (well documented by centrist academics like Jon Haidt, among others–see here and references therein), and the result is a community that seems solidly united against the President-elect. (That said, I’d note that I’ve met more than a few political independents within academia who chafe at current norms.)

The problem, of course, is that science matters to America and to Americans. The U.S. scientific ecosystem has advanced knowledge and powered a range of industries, from biotech to aerospace. America has a wonderfully robust tradition of supporting scientific exploration, and it’s hardly surprising–but worth noting–how many great scientific advances, including many resulting in Nobel Prizes, were made by researchers originally from other countries attracted to the United States by the freedoms of our nation.

Many Trump critics argue passionately against participating in the Trump Administration, essentially suggesting that joining the team would help legitimize an unworthy (some would say execrable) regime. (In a small, informal and unscientific Twitter poll I did over the weekend, about a quarter of respondents were in this category.)

The alternative view is that in a Trump administration, it’s especially important for rigorous scientists to participate and be heard–provided, of course, that their voices would be heard, rather than their prestige co-opted. Because so few scientific innovators seem to be drawn to the Trump team, those who participate may find themselves–like Silicon Valley VC Peter Thiel – with an opportunity for influence far greater than they would have had in a more traditional administration.

To this end, one name that immediately comes to mind as a potential biomedical advisor or potential appointee is Dr. Jeffrey Flier, who recently stepped down as Dean of Harvard Medical School, after nearly a decade in that role.

(Disclosure: I know Flier as an endocrinologist and colleague, but do not have a personal or business relationship; I do have a long history with the university, including a current adjunct/visiting scientist appointment.)

In addition to deep expertise in medicine and science, and a range of honors including elected membership in the National Academy of Medicine, Flier has three attributes that would presumably appeal to the Trump administration.

First, Flier has encouraged the university to embrace entrepreneurship while remaining true to its academic foundation–an incredibly difficult needle-threading challenge that he somehow seems to have pulled off, a testament to his vision, independent thinking and political aplomb.

Second, Flier’s striver background is arguably similar to Trump’s: on the way to becoming Dean at Harvard, Flier went to City College of New York, and received his MD and subsequent training at Mount Sinai School of Medicine. He rose through the ranks at Harvard’s Beth Israel Hospital, which might be viewed as Boston medicine’s version of coming from the Outer Boroughs (see this Samuel Shem classic for more detail).

Finally, Flier’s love of medicine is clearly part of the family business; his wife is also a professor of medicine at Harvard, his brother as an internist in the Boston area, and his two daughters are physicians as well.

While Flier has suggested on Twitter he has no interest in being considered for a role in the new administration, Trump’s team would do well to do whatever they could to bring him into the fold.

Our nation’s continued leadership in biomedical science is vitally important for our collective future. The new administration must seek to recruit the best talent–even NeverTrumpers, like Flier; similarly those who are tagged–even NeverTrumpers–must consider serving, for the benefit of the country.

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What Does the Recent Election Mean For Predictive Analytics In Healthcare???

By ROBERT ROWLEY, MD

The outcome of the recent election caught many people, and many forecasters, by surprise. How could their predictions have missed the mark so significantly? Granted, there were a number of people who predicted the outcome more accurately, but many of those who used data models to analyze the likely outcome are left now with head-scratching and postmortem analysis in order to improve their methods.

In their book Superforecasting, The Art and Science of Prediction, authors Philip Telock and Dan Gardner describe a subset of people who, on average, are significantly more accurate in their ability to predict upcoming events. “What makes them so good is less what they are than what they do—the hard work of research, the careful thought and self-criticism, the gathering and synthesizing of other perspectives, the granular judgments and relentless updating.”

What does this mean for healthcare? I’m not talking about the impact of the new presidency on health policy and healthcare delivery (that’s another discussion) – I’m talking about whether predictive analytics is really all that accurate in the first place. Where does it fail?

The strengths and weaknesses of predictive analytics

Predictive Analytics in healthcare, a buzzword in the industry for a couple of decades, is the science of determining which populations are likely to become ill, what the health and cost implications of that are, and what might be done by way of pre-illness intervention to change things. About 20% of the population consumes 80% of health care dollars. But those who are catastrophically ill this year are not necessarily the ones who will become catastrophically ill next year – the high-cost cohort, though a consistent finding year after year, will be comprised of different individuals each year. The goal of medical Predictive Analytics is to figure out who will likely drop into that high-cost bucket next year, and what can be done to reduce that risk.

Much of risk stratification (the core of medical Predictive Analytics) is focused on populations. Taking people with certain health risk parameters in aggregate, as a population, is something that is predictable, can be measured and studied, and is the basis of what we have now. But drilling that understanding down to an individual patient becomes much more uncertain. Should this diabetic patient, controlled with medications but not on a statin, and who has at-target LDL cholesterol levels for a diabetic – should this patient be prescribed statins anyway? Doctors will have differing opinions, will do different things, and will look to supporting data (which may be sparse in a more granular analysis) to justify their choices.

How can we get better at individualizing medical recommendations? How can we take the current state of Predictive Analytics, which concerns itself with population management, and move it forward to something more precise?

AI: the next step in prediction

This is where Artificial Intelligence (AI) in healthcare can be very powerful. AI is the intersection of Machine Learning (ML) – a set of self-teaching algorithms that can identify patterns in data without being pre-programmed on what to look for (therefore without “pre-analysis bias”) – and the application of that ML to very large data sets. The shortcoming of medical AI so far is not so much a shortcoming in ML algorithms, but is the lack of very large, normalized data sets on which it can work. Medical data (clinical data) is historically fragmented into institution-centered silos, and claims data is segmented into payer silos. Aggregating this data into huge data sets is the task at hand in order for AI to become meaningful.

From this effort, our Medical Knowledge Graph (MKG) can be extraordinarily useful. The Flow Health Medical Knowledge Graph is the organized result of AI insights built in a way that can be used on-the-fly by a variety of medical applications, such as Electronic Health Records, population management and reporting tools for value-based care, web tools, and patient-facing apps. For the patient described above, the individualized recommendation can be made for that given person, and take into account all the diagnoses, lab values, medications used and discontinued in the past, and genetic markers if known.

Does this technology, once it matures, make the doctor’s role obsolete? No. It makes the doctor’s role more precise, more accurate, more consistent. In clinical medicine, we use clinical judgement based on recognizing a pattern presenting in a given patient, and we try to match that against similar patterns from our learning and our experience. We then use that pattern-matching to make recommendations. In the case of AI and the MKG, the pattern can be described in more detail, and the comparison is done against the entire body of data available to the ML engine. It becomes a tool that can make clinical judgement much better informed.

Predictive analytics, and the AI tools now becoming available, predict the odds of success, or the odds of something occurring. They deal in probabilities. However, as noted by many forecasters, nothing is truly certain (until it happens). Failures of accurate prediction teach the learning engines. This is true in political outcome prediction, and it is true in medicine. Leaders, whether in government, in the military, in business, or in healthcare, need to be well-advised, but must make executive decisions. In healthcare we call that making a surgical decision (there are no erasers on the ends of scalpels). Clinicians need to be decision-makers, informed by the best analytics available. In health IT, we need to build the best analytics engines we can, so as to inform medical decision-making in the best way that technology allows.

Robert Rowley, MD is Chief Medical Officer at FlowHealth

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One Regulation Could Eliminate a Dozen Others

By ADRIAN GROPPER, MD

President-Elect Trump recently announced: “for every one new regulation, two old regulations must be eliminated.” Regulatory capture, the topic of a recent THCB post by Nortin Hadler, has enabled many regulations based on HITECH that restrict competition by allowing information blocking. Many other regulations around quality measures, documentation, decision support, contract transparency, and kickback safe harbors are now needed to counteract EHR vendor consolidation through regulatory capture.

One regulation designed to establish a patient-controlled interface (a patient-controlled API) to health records will enable competition for all aspects of the institutional EHR by decentralizing access to the patient information. The impact on health reform, ACA reform, and medical research would be immense.

“Give me the place to stand, and I shall move the earth.” If Archimedes were moving healthcare practices and politics then data would be his lever. The data to move healthcare is much more than a hospital’s EHR will ever be trusted with. It includes the social determinants of health, it includes employment and exposure, it includes your genome and family, it includes personal beliefs.

The data to move healthcare practices and politics does not split cleanly between research and clinical uses. Sync for Science is not enough to provide independent decision support at the point of care. Access to detailed personal data spanning the full range of human experience and aggregated over a lifetime is now technologically possible. Who can be trusted with this formidable power?

Nobody but ourselves. Regardless of how well-regulated and well-organized our healthcare and government institutions might be (need we review the cybersecurity track record of either hospitals or government?), the only one to be trusted with knowing everything about me is me.

The world is full of institutions and people that know something about me. Some, I know about. The vast majority are hidden data brokers. Surescripts, Acxiom, Lexis-Nexis, Optum, IMS, All Payer Claims Database, and Prescription Drug Monitoring Programs are all collecting and selling as much about me as they can. It’s their only business and I am the product. Even as the patient surveillance industry has boomed along with my out-of-pocket costs, transparency of health care quality or cost is as elusive as ever.

As Doc Searls recently commented: “Economically speaking, the American health care system is not built for patients, because patients aren’t the ones paying for it directly. Insurance companies are.” This well-known technology journalist speaks in favor patient-centered health records.

Technology now makes it possible for each of us to control more and better data than the hospitals and data brokers. That means each of us as patients would have more leverage to move health care and health insurance practices. Instead of buying our information from hospitals and data brokers, our providers, researchers, and regulators would be getting the information by asking us. By asking us.

Which leaves one major contingency: Who would pay to give us patients the ability to control our own health records? A less regulated, more market-driven health system is now technically possible but it requires investment and a sustainability plan. In the long run, patients facing many thousands of dollars in out-of-pocket expenses will see the wisdom of spending a few hundred to inform their spending. More immediately, and aligned with whatever policies a Trump administration brings to health and human services, we might see pharmaceutical companies, insurance companies, and public institutions – anyone that would benefit from better access to patient records in a value-based payment system – invest in patient-centered health records. It all starts with one well-designed regulation to replace information blocking with “Just ask me”.

Adrian Gropper is Chief Privacy Officer of the Privacy Rights Foundation.

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Asian Chicken Lettuce Wraps

Dinner tonight was awesome! I made these Asian Chicken Lettuce wraps from The Paleo Diabetes Diet Solution cookbook. While I don’t have diabetes and I’m not “paleo”, as you might already know from my latest “10 Things about Me” video, I do love a healthy and tasty recipe. These wraps are blood sugar balancing and very satisfying. I had two and I was perfectly happy. 

Usually I am not a huge fan of recipes with a long list of ingredients, but believe me when I tell you this recipe was worth it! And it wasn’t labour intensive – just a lot of ingredients. I made a few changes based on ingredients I had on hand so I didn’t have to do a whole new grocery shop.

Lucky for me, we have leftovers too. This could easily feed a hungry family. I feel like Walker and I barely made a dent in that bowl!

This recipe is gluten-free and dairy-free however as I was eating it I thought to myself this would be really nice with some goat feta sprinkled on top. That would kinda ruin the Asian vibe though seeing as feta isn’t usually in asian dishes. 

Walker said he would have rather had a hard shell taco or fajita with it but I loved the lettuce wrap. My belly is happiest without many grains anyhow, so I was quite pleased with dinner.

Vienna didn’t have any but that’s only because she’s not feeling well right now. She got a head cold about 10 days ago and as soon as it seemed like she was better it morphed into something else. Last night we had to take her to Sick Kids Hospital because things escalated but she’s on the mend now. It was pretty scary, I was in tears en route to the hospital but I guess that’s pretty normal when your baby is sick for the first time. Or maybe I’m just a big suck. Probably the latter.

Okay let’s get to this tasty and nourishing recipe shall we? 

Asian Chicken Lettuce Wraps

2016-11-28 19:44:28

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Ingredients

1. SAUCE
2. 2 garlic cloves, minced
3. 1 tbsp ginger root, minced
4. 1 tbsp fresh cilantro*, chopped
5. 1 tbsp sesame seeds
6. 1/4 cup tamari
7. 1 tbsp lime juice
8. 1 tbsp rice vinegar
9. 1 tsp fish sauce (I omitted this because I didn’t have any)
10. 1 tsp toasted sesame oil
11. I added: 1 tsp real maple syrup
12. STIR-FRY
13. 1 tbsp olive oil for sautéing
14. 1lb organic ground chicken
15. 2 celery stalked, finely chopped
16. 1 carrot, finely chopped
17. 1/2 red pepper, finely chopped
18. 1 cup snap peas (I didn’t have any so I used frozen sweet peas)
19. 1/2 cup onion (I used red onion) finely chopped
20. 1 garlic clove, minced
21. 1/2 cup shiitake mushrooms (I didn’t have any so I used crimini)
22. 1 tsp ginger root, minced
23. 2 green onions, chopped
24. LETTUCE CUPS
25. 12 Boston lettuce leaves (I didn’t have any so I used Romaine and turned these into “wraps”. The original recipe is called “cups”)
26. 1 cup bean sprouts (I used sunflower sprouts)
27. 1/4 cup fresh cilantro*, chopped
28. 1/4 cup cashews, toasted and chopped (I just used raw, unsalted)

Instructions

1. Sauce: In a small bowl, combine garlic, ginger, cilantro, sesame seeds, tamari, lime juice, vinegar, fish sauce (if using), sesame oil and maple syrup (if using). Set aside.
2. Stir-fry: In a large skillet, heat olive oil over medium high heat and add chicken and cook until it’s no longer pink. Add celery, carrot, red pepper, peas and onion. Stir fry for a few minutes. Stir in garlic, mushrooms and ginger. Add half the sauce to the pan. Cook for 1-2 more minutes then transfer to a large bowl and top with green onions.
3. Lettuce wraps: Fill lettuce leaves with stir fry and top with bean sprouts, cilantro and cashews. Drizzle remaining sauce over top as desired.
4. The next time I make this I will double the sauce ingredients.
5. ENJOY!

Notes

1. *Hate cilantro? Use parsley instead.

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I just love the photo above because just seeing it reminds me of how incredible cilantro smelled. I think someone should make a cilantro perfume? Don’t you think? haha! Okay maybe not but chopping and smelling it makes me feel so gosh dang joyous! Sorry to those who hate cilantro out there, you could  swap it with parsley instead.

I loved that there were so many detox-friendly ingredients in this recipe from cilantro to sprouts to green onions that this recipe could easily 

As sign of a great dinner is looking forward to leftovers the next day and that’s exactly how I’m feeling right now!

Have a joyous rest of your week!

Joy

Joy McCarthy

Joy McCarthy is the vibrant Holistic Nutritionist behind Joyous Health. Author of JOYOUS HEALTH: Eat & Live Well without Dieting, professional speaker, nutrition expert on Global’s Morning Show, Faculty Member at Institute of Holistic Nutrition and co-creator of Eat Well Feel Well. Read more…

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Why Trump Won? A Brief Tutorial for Harvard Medical Students

By ANISH KOKA, MD

Mike Milligan, a Harvard medical student, recently wrote in THCB about the shock felt throughout his medical school upon the election of Donald Trump.  Seeking to understand how it may be that ‘equality, service and compassion’ were defeated, Mike settles on the narrative that appears to have taken hold of the elites on the left – Trump did not really win, Hilary lost.  While he does not say so in explicit terms, clearly we are to understand that the recent election was lost, and that in order to assure a better outcome the next election, physicians should urge their patients, and particularly their ‘poorer and less educated patients’ to register to vote.   Hopefully, these voters can then ensure that access to ‘affordable, high-quality medical care’ through constructs like Obamacare and MACRA are nevermore placed in jeopardy.

What complete hogwash.

Let me start with the factually incorrect parts.

Mike writes that ‘Mr. Trump received fewer votes in victory than the previous two republican nominees garnered in defeat.’  As of today Donald Trump has received 62.2 million votes out of a total of 126.6 million votes cast.  Mitt Romney received 60.9 million votes out of a total of 126.8 million votes, and John Mccain received 59.9 million votes out of a total of 129.4 million votes cast.  So despite the fact that his opponent raised and spent close to 1 billion dollars on ads promising the literal apocalypse if Trump was elected, no republican candidate in history garnered more popular votes than Donald Trump.  While it is true that nearly half of all Americans did not cast a ballot in this election, 3 million more votes were cast in 2016 than were cast in 2012.  The percentage of eligible voters casting their vote in 2012 was 55%.  The percentage of voters casting their vote in 2016?  Also 55%.  I realize the desire to deligitimize Trump by arguing this was a low turnout election that delivers no mandate is a very strong one among the millions on the losing side.  Unfortunately, wishes and reality sometimes find themselves in conflict.

The real story of the election is that the Donald Trump managed to flip the rust belt states of Michigan, Wisconsin and Pennsylvania by convincing blue-collar, mostly white voters that his party was now the “workers’ party”.  Traditionally blue strongholds of towns like Erie, Luzerne, and Northampton counties in Pennsylvania turned red in 2016. A Republican hasn’t won Erie County since 1984!  Obama won this county  by 16 percentage points in 2012 – Trump won this same county by 2 percentage points.  Statewide, Trump performed better than Romney in 58/67 counties while Clinton performed worse than Obama in 65 counties.  So it is absolutely true that Clinton performed worse than Obama, but not to focus on the story of the overperformance by Trump is to be willfully blind.

As to the implication that it was the least educated sitting at home that sunk Mrs. Clinton, data would argue the opposite.  The poorly educated did vote, and by a wide margin chose Trump.  Pre-election polling showed Trump with a 30-percentage point advantage among whites without a college degree – he ended up winning them by 40 points.  Indeed, one of the single best predictors identified in counties that swung to Trump is the percentage of non-college whites.  The greater the percentage of non-college educated whites in your county, the greater the chance of Trump emerging victorious.

The only metric found to be even more predictive than your race and education?  Poor health. You are reading that correctly.  In an analysis done by the Economist , a weighted index of obesity, diabetes, heavy drinking, physical exercise, and life expectancy performed even better than race and education level in predicting counties that moved to Trump.  The poorer your health, the more likely you were to vote for Trump.

A wonderful interactive version of the graph can be found here.

Apparently, those who stood the most to gain from affordable, high quality health care were also most likely to choose the candidate who called for repeal of Obamacare.  It is safe to say that this was a stunning repudiation.  To a great many who had voted for the promise of Obamacare, the reality of high premiums, penalties, and narrow networks left a bitter taste.  And so it came to be that those uneducated and in poor health – the losers in this economy – chose the candidate who promised change over the candidate whose campaign slogan was grabbed from the recent Lego movie – “Everything is Awesome”. What a complete shock.

There are many story lines that underlie Hilary Clinton’s defeat.  She was clearly unable to animate and connect with her base in the way Barack Obama did – but if this is the major narrative rocking liberals to sleep in these cold dark times, I would advise the overworked mental health specialists dealing with the trauma of a Trump election on college campuses to pace themselves for eight years of inconsolable sobbing.

Anish Koka is a cardiologist in Pennsylvania.

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Holiday Cookies! Fruit and Nut Thins

This year, Chatelaine magazine launched a Holiday Cookie Exchange with a few foodie-obsessed friends like me. I shared a recipe for my Chocolate Chip Tahini cookie, which is a joyous-reader fave! Have you made it? And the Chatelaine kitchen team sent me a recipe to try these “Fruit Thins” from their holiday cookie collection. 

Of course in joyous style, I had to change this recipe just a bit to make it friendly for the joyous community — YOU! The main ingredients I changed were instead of white flour I used spelt flour, instead of sugar I used to maple syrup, instead of butter (I’m not against butter I just wanted to make it as friendly for all dietary choices as possible) I used coconut oil. I also added some more spices like ground ginger and ground cinnamon. In fact, we could easily call these Spicy Fruit and Nut thins.  

I also halved the recipe because it makes 40 cookies and I don’t know what I would do with that many cookies between Walker and Vienna and I — eek. It would be dangerous really! However, the recipe I have included below does make 40 cookies. If you want to make about 20 cookies instead, just divide every ingredient in half. It also makes it a bit easier when you get to the part where you slice the near-frozen batter because you don’t have to cut it crosswise.

These cookies really remind me of skinny biscotti. In fact, you could even bake them a little longer to make them even more like a biscotti-texture if you like!

I have to admit, I was really unsure how these were gonna turn out because I changed ingredients and also changed up the method a bit. They turned out AMAZING and will definitely be on my holiday cookie recipe list for years to come.  

 Just make sure no matter what, you use high-quality ingredients. I went to my local health food store and bought these organic hazelnuts, pistachio’s and sulphite-free cranberries (notice their not bright red). Shopping in bulk for these type of ingredients is a cheaper way to buy organic. Note: hazelnuts are pretty damn expensive, so feel free to swap with raw almonds instead

 Be sure to scroll all the way down to see 5 more cookie recipes!

Holiday Cookie: Fruit and Nut Thins

2016-11-26 17:07:36

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Ingredients

1. 1 3/4 cup spelt or kamut flour
2. 1 tsp baking soda
3. 1 tsp ground cardamom
4. 1 tsp ground cinnamon
5. 1/2 tsp ground ginger
6. Pinch of fine sea salt
7. 1/3 cup water
8. 3/4 cup maple syrup (There is quite a bit more sugar in the original recipe)
9. 1/2 cup melted organic butter or melted coconut oil (I used coconut oil)
10. 1/2 cup shelled pistachios, coarsely chopped
11. 1/2 cup roasted hazelnuts, coarsely chopped (original recipe says to peel them but I didn’t — I was being lazy)
12. 1/3 cup unsulfured dried cranberries
13. Optional: 1/2 cup orange peel (You could just use a cheese grater to get the zest from the orange)

Instructions

1. Preheat oven to 350F.
2. Line an 8 × 4-in. loaf pan with plastic wrap.
3. In a large bowl, combine flour, baking soda, spices and fine sea salt.
4. In a separate bowl, combine water, maple syrup, melted coconut oil, nuts and cranberries.
5. Add the wet ingredients to the dry and mix until just combined.
6. Place into the loaf pan you lined with a large piece of plastic wrap. Press the mixture down and make sure it’s covered by the wrap. Freeze batter for 2 hours.
7. After 2 hours, remove batter from the freezer. If you did NOT half the recipe, then you’ll have to cut the batter into half crosswise (I know.. that sounds confusing, but you’ll know what I mean once you make it). And then slice each cookie about 1/3 of an inch thick.
8. Line a cookie sheet with parchment paper and place cookies on sheet.
9. Bake for 12-15 minutes until golden brown.

Notes

1. Makes 40 cookies. As per my notes above, I divided every single ingredient into half because 40 cookies would just be asking for trouble in my home, ha! Dividing some ingredients in half like the flour was a super odd measurement so I just ballparked it and it turned out perfect, so don’t stress about it being 100% accurate.
2. By the way, taste the batter to make sure it’s sweet enough to your likely. I significantly reduced the amount of sugar.

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By the way, I will be participating in Chatelaine’s Facebook Live on Wednesday November 30, 6:00 p.m. at Chatelaine’s holiday party. I will be sharing cookie tips and tricks with the editors and tasting all the sweet treats. Be sure to watch! 

Since it’s the season for all things cookies, I’ve linked some more of my favourite holiday cookie recipes below for you.

Gluten-free Raspberry Jam Cookies

Healthy Digestive Cookies

 

Gluten-free Chocolate Chip Quinoa Cookies

 

Good Day Breakfast Cookies

Chocolate Breakfast Bark (but you can eat it anytime of day!)

Happy Holidays!

Joy

Joy McCarthy

Joy McCarthy is the vibrant Holistic Nutritionist behind Joyous Health. Author of JOYOUS HEALTH: Eat & Live Well without Dieting, professional speaker, nutrition expert on Global’s Morning Show, Faculty Member at Institute of Holistic Nutrition and co-creator of Eat Well Feel Well. Read more…

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The Uncertainty Bomb

By PAUL KECKLEY

I like certainty and routine. I like my daily Tall Dark Roast with no room for cream at 5 am at Starbucks. I like the same restaurants, the same suits and ties and the same TV shows. Holidays throw me off and I get bored quickly when I have down time.

For six years, the healthcare industry in the U.S. has been adjusting to its new normal based on the regulatory framework of the Affordable Care Act (ACA). It became routine to discuss the volume to value, accountable care organizations, bundled payments, Medicaid expansion and Healthcare.gov. We were certain they’d be around for years to come.

Then came the election. When 61 million voters elected Donald Trump to the White House and kept GOP majorities in both houses of Congress, it signaled our routines in healthcare would be disrupted. The campaign promised to repeal and replace the ACA: its repeal appears certain but it’s replacement injects uncertainty into our routines around a number of meaty issues:

• Senate Composition: The mechanisms for replacing key elements of the law will require a super majority of 60 in the Senate: will the 52 GOP senators broker support from 8 Dems for weighty items like how Medicaid block grants could work, how consumers could buy insurance across state lines, how tax credits would work as individuals replace employers as the key insurance market, the potential for vouchering Medicare and much more. How the Senate advances the ACA’s replacement will be a protracted process with many moving parts and considerable political deal making.
  
• Federal Budget: Healthcare spending by the federal government is 30% of its total spending. The tension between budget hawks in Congress who fear escalating deficits and the Trump team’s promise to invest $550 billion in infrastructure including hospital improvements will require deft political craftsmanship. Funding for healthcare will compete against pressures to reduce federal spending pitting it against education, transportation, homeland security and defense for budget consideration. And GOP partisans vow cuts to healthcare spending which, in some cases, are at odds with Trump campaign promises.
  
• Health Insurance: Creating a new regulatory framework for private health insurance will be complex and time-consuming. Uncertainty about the individual insurance market is particular unsettling and the future of marketplaces unknown. Will the new administration ease restrictions on private insurers that result in higher premiums? Will the individual and employer mandates that are repealed be replaced by other mechanisms that induce coverage and spread risks? Will the shift of financial risk and affordability to providers from insurers accelerate the growth of integrated health systems that operate hospitals, sponsor health plans and networks of clinicians? There are 106 of these today: is integration of financing and delivery the future? And what’s to become of the 21 million who gained insurance coverage through the ACA, including the 12 million who expect to get subsidies to pay their premiums (estimated at $43 billion this year).
• Consolidation: What’s the future for industry consolidation? Will FTC recent constraints on health system consolidation in Pennsylvania and Chicago be sustained or revisited as appointments to key posts in the Department of Justice and FTC are made. What’s the view of the new administration toward mega-mergers like CHI-Dignity Health, Aetna-Humana and Anthem-Cigna to name a few.  And will the Trump affinity for  free market competition lead to mega-players akin to other industries like banking where five organizations control 45% of assets nationally, airlines where 4 carriers control 80% of passenger miles flown?
  
• Veterans Health et al: And how will the new administration orchestrate pledged improvements in veteran’s health, lower drug prices, protection of Medicare, trade agreements and tax reforms that impact U.S. drug and device manufacturers that operate globally and much more?

Answers to these are unknown. And they’ll not be found overnight. That’s the new, new normal. Uncertainty.

Most healthcare organizations put their 2017 Strategic Plans to bed before the election. Capital and operating budgets are already in place as by-products of their planning effort. Each is based on assumptions that carry a high level of certainty.  The election results changed things for many.

The new, new normal in U.S. healthcare is about navigating uncertainty.

For drug and device companies, the news is mostly good. Though the 12 nation Trans Pacific Partnership trade deal appears dead and the Trump campaign railed against drug prices, price controls appear unlikely.  The elimination of excise taxes on medical devices and mandated discounts for prescription drugs appear likely. The administration is likely to focus on streamlining the FDA’s approval process to create more competition which could take years. That’s the reason their stocks in these sectors have gained 10% since the election.

Ditto good news for the health insurance industry. Repeal of the ACA means onerous requirements like essential health benefits and premium increase constraints go away. They’ll benefit from greater flexibility in setting premiums and benefits design. No doubt, they’ll negotiate around guaranteed issue and risk-ratings to strengthen their bargaining position. The marketplaces will be auctioned off to the states, and commissions will be created to define a path forward for private coverage just in time for the 2018 elections. All in all, good news.

For health information technology companies, the news is mixed: there’s no evidence meaningful use will be suspended at last through Stage Two since its funding is outside the ACA, but fear that hospitals and physicians might pull back investing in HIT given mounting uncertainties is evident. Digital health and telemedicine sectors are the exception as the healthiest hospital systems advance their care coordination and population health management efforts but solution providers in both sectors are plenteous and standards around privacy and security risks a work in process.

But for providers, especially hospitals, the election outcome is particularly unsettling. As insurers gain leverage and employers press for lower costs, they’ll hammer physicians, hospitals and post-acute providers for steeper discounts. Medicare’s path will be an unknown for a while: will the GOP successfully orchestrate its transition to a premium support model? Will its mandated bundled payment and value-based purchasing programs carry over as a new CMS team steps in? As Medicaid is transferred back to the states via block grants, will providers be commoditized by the private Medicaid managed care organizations currently used in 39 states to keep costs/beneficiary low? For physicians, MACRA isn’t likely to go away: the election assures that at least 90% of eligible physicians will simply opt for its lower risk MIPS payment model until the dust settles around alternative payment programs like ACOs. Thus, for all providers, uncertainty is reality. And for hospitals, the uncertainty is precautionary.

In most hospitals, boards and management are meeting to revisit their 2017 plans in light of the election results. Like early-stage prostate cancer for men, watchful waiting is a reasonable response to the new, new normal. Uncertainty can be debilitating but a few things are clear:

The certainty of escalating cost pressure. Operating margins for hospitals will shrink faster than anticipated. The potential suspension of insurance coverage for 21 million newly insured means increased bad debt for hospitals. That’s reality. Scale and scope need fresh attention: affiliations and partnerships make more sense now than ever. And cost reduction efforts will take center stage beyond the bread and butter punch list promoted by most consultancies– supply chain improvements, workforce productivity, capital costs for bricks, sticks and technology, and formulary design. Clinical process redesign will be first and foremost: a recent Truven analysis showed savings of $400 per admission in cardiology, gastroenterology and other key programs that are designed around efficiency and effectiveness—more than savings in formulary design and other staples in cost reduction. These expanded hospital cost reduction efforts will necessitate attention to medical practice operational performance since one in three physicians is now a hospital employee and compliance risk mitigation to avoid penalties for safety lapses, avoidable errors and suboptimal outcomes. Add cost effectiveness in data capture necessary to quality, safety and costs, rationalizing of health information technology investments, surgical precision in the design of health insurance benefits for hospital employees and openness to outsourcing virtually every function where efficiency and effectiveness gains can be realized—that’s the widening domain of hospital cost reduction. And it’s certain to be a priority.

The imperative of physician leadership. Physicians aren’t happy. The majority in their ranks believe the health system is deteriorating as their clinical autonomy is challenged and incomes threatened. Being an employee of a large medical group or hospital is not a desired end-game for many but remaining independent seems a pipe dream to most. And the complexity of clinical practice—adherence to evidence, measuring and monitoring outcomes and patient experiences, engaging peers in care coordination, converging behavioral, physical and alternative health disciplines in diagnostics and treatment planning, and acclimating to person-centered care that’s transparent—is daunting. Hospitals bear the brunt of these understandable feelings: they’re intense. Effective physician leadership will be imperative in every sector of healthcare as the new, new normal unfolds. It requires business savvy that compliments clinical training: as financial pressures mount and regulatory expectations change, understanding creation of and access to capital, compliance risks, workforce performance, and day to day operations will be as important as acumen in understanding signs, symptoms, risk factors and co-morbidities. System-building is the future: that’s certain. And those activities, programs, investments, relationships and business interests will revolve around capable physician leadership and financing and delivery are fully integrated.

The centrality of person-centered services. Individuals in every stage of health are the most important stakeholder in the new, new normal. Patient-centered care is limiting: it conveys a paternalistic demeanor toward individuals lending to widespread variability in access, costs and outcomes. It’s limited to inpatient and outpatient services delivered by providers to patients. That’s not the future. Employers are pushing away from conventional coverage forcing employees into high deductible plans. Social media and digital health are providing meaningful comparisons of providers, drugs and plans conveniently and credibly. Health is being defined more broadly around concepts of wellbeing in which social determinants and community programs matter. Alternative health, retail services, telemedicine and online services are as critical in the new, new normal as beds and clinics. Healthcare organizations that default to traditional views of individuals as patients and enrollees risk a growing opportunity for growth and innovation. Transparency in interacting with individuals will be more important than ever: the unintended consequence of Campaign 2016 is widespread public disillusion with established institutions and suspicion about “fake news”.  That’s the reality of the new, new normal.

The election 12 days ago assures uncertainty in U.S. healthcare. Across our system, the unknowns outweigh the knowns. The new, new normal need not be paralyzing: it presents new opportunities for organizations that adapt.

Paul

P.S. The election surprised many. In this Thanksgiving season, we should celebrate a system where our periodic political campaigns are the basis for the governing of our Republic. Regardless of the outcome, we live in a system that’s imperfect but still “of the people”.

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How Doctors Could Win the Next Election

By MIKE MILLIGAN

On the morning of November 9^th, the day after the 2016 U.S. Presidential Election, a visceral sense of shock was felt throughout the campus of Harvard Medical School. Donald Trump’s victory appeared to be an abrupt rebuke of so many of our commonly held values—equality, service, compassion. As medical students and physicians in Boston, we understood that we were isolated—both geographically and ideologically—from the myriad forces that swept Mr. Trump into office. However, there was something unsettling about our collective disbelief. How was it that so many of us had failed to recognize the depth of pain and divisiveness that existed within our country? There arose, in all of us, a need to understand.

In the aftermath of the election, political analysts have ascribed Trump’s victory to several themes—condemnation of the intellectual elite, widespread economic disaffection, and the rise of a potent strain of populism.  However, closer inspection reveals another contributor to this startling election result. Though the final votes are still being tallied, it is clear that Mr. Trump will have received fewer votes in victory than the previous two republican nominees garnered in defeat. Instead of representing a powerful mandate, Mr. Trump’s victory hinged on vast portions of the electorate choosing to stay home. Nearly half of all Americans did not cast a ballot in this election¹. As captured poignantly by Jon Favreau, former speechwriter to President Obama, “democracy is fragile and belongs to those who show up.” 

With this in mind, what can we as medical students, physicians, and allied healthcare professionals—no doubt part of the “intellectual elite”—do to heal the personal and societal wounds from this election? How can we ensure, going forward, that the values to which we adhere remain secure? Answers to these questions will likely require significant reflection, but we believe that democracy is at its best, and most equitable, when all voices are heard. Therefore, we suggest that there is meaningful and feasible action that we can take today. We can help our patients register to vote. 

Voter Registration in a Healthcare Setting is Meaningful

Since the pioneering work of Rudolf Virchow in the 19^th century, generations of physicians have sought to improve the social factors that cause illness among their patients. This advocacy has led to, among many others, the provision of safe drinking water, widespread access to vaccines, and campaigns to reduce cigarette smoking. More recently, physicians have focused their attention on the so-called “social determinants” of health—factors like housing instability, poor nutrition, and occupational exposures. The number and scope of interventions designed to improve social determinants have expanded dramatically, and in an effort to focus physicians on the most impactful projects, Russel Gruen and colleagues developed a novel framework. Put forth in a 2004 special communication in JAMA, they delineated between professional obligations—which address social issues that both directly cause illness and are amenable to change—and professional ambitions—which tackle the broader social factors that indirectly affect health². Professional obligations must come first in any provider’s agenda, but ambitions too should be championed. Voting, of course, does not directly cure disease, but it can empower citizens to influence society around them. A vote for any candidate or platform propels a particular healthcare agenda, whether it defends or denies women’s’ reproductive rights, raises or lowers the price of prescription drugs, or expands or narrows access to healthcare. Our system is most equitable when all voices are heard, and regardless of one’s own political stance, promoting voter registration is a worthy aspiration.

Voter registration in the U.S. is indeed problematic.  Driven by low overall rates of registration, turnout for American elections is lower than in almost every other developed country around the world³. Additionally, wide discrepancies in voter turnout exist across demographic groups. For example, in 2012, Asians and Latino Americans voted at a 20% lower rate than whites or blacks. Poorer and less-educated citizens turned out at roughly half the rate of their more affluent peers, and similarly low levels of voting were observed among Americans with disabilities and unstable housing opportunities⁴. While not yet fully characterized, the results from this month’s election are likely to show a familiar trend.

The same demographics least likely to vote are also those with the poorest health in our society. Failing to vote, of course, does not lead to poor health, but the two are certainly related.

A 2001 study found a striking connection between voter participation and self-reported levels of health. Stated simply, citizens in states with the greatest voting disparities between rich and poor tended to rate their health poorly, whereas citizens of more equitable voting states rated their health better. This difference remained significant even after controlling for baseline levels of wealth and income inequality⁵. The connection between a state’s voter turnout and overall health seems peculiar, but Kim Qualie Hill, a professor of political science from Texas A&M University, and his colleagues posited one explanation. In an article published in the American Journal of Political Science, they found that electorates that contained fewer low-income voters tended to have less generous social welfare systems⁶. They reasoned that administrations enact legislation that favors their electoral coalitions, and that higher-class interests—overrepresented in such blocs—are often at odds with policies benefitting the poor. These findings suggest that, by failing to vote, society’s most disenfranchised citizens are forgoing a powerful opportunity to improve their conditions, health among them. 

Voter Registration in a Healthcare Setting is Feasible

In the clinic patients come first, and while many healthcare providers aspire to make sweeping improvements in socioeconomic inequalities, time is increasingly constrained. So how can busy practitioners find time to address professional ambitions like voter registration? Luckily, recent experiences inform a practical path forward.

Studies have shown that many unregistered voters simply lack the initiative, time, or understanding to navigate the registration process, but are receptive to assistance. Citing the National Voter Registration Act of 1993—which encourages providers of public assistance, like Medicaid services, to build voter registration capacity—the National Association of Community Health Centers ran a voter registration drive in 2008. Through their efforts more than 18,000 low- and middle- income citizens were added to the official rolls. Another program, conducted in 2012 at two Federally Qualified Health Centers in the Bronx, showed that a large number of voters could be registered easily without requiring significant physician effort, compromising patient-doctor relationships, or creating undue political influence⁷. Patients were simply asked about their voter registration status while waiting to see their doctor. If they were unregistered but interested in voting, clinic staff provided them with voter registration cards and answered any of their questions. Completed forms were then mailed to the Board of Elections. In all, each registration took as little as 5 minutes to accomplish.

It is important to note that it would be inappropriate for physicians, with their institutional and professional power, to coerce their patients to adopt specific political beliefs or actions. However, these studies showed that when performed as a nonpartisan public service, either by clinic employees or physicians themselves, voter registration drives do not pose legal or ethical concerns. While it is unclear how many of these patients subsequently cast a ballot in an election, registering to vote represents a substantial step in the right direction.

Path Forward

Now is the time for healthcare providers to facilitate voter registration among their patients. We are poised at an uncertain time in the course of our democracy, and recent events have put the future direction of healthcare into question. President-Elect Trump vowed during his campaign to repeal the Affordable Care Act—an idea likely to be welcomed in the GOP-controlled congress. Additionally, roll out of the Medicare Access and CHIP Reauthorization Act is set to begin in 2017, and the tenor in Washington will likely play a major role in how the law is instituted. Although the legislative agenda over the next 4 years remains unclear, it seems likely that millions of Americans are in jeopardy of losing access to affordable, high-quality medical care. However, if it is the will of the voters, future laws might be enacted to strengthen our healthcare system. Whatever direction, everyone should have a say in their health.

The success of a democracy, by definition, depends on the engagement of its participants. Healthcare providers, by virtue of serving all patients, are uniquely poised in society to understand the diverse needs of a diverse populace. Physicians already counsel their patients to quit smoking, adjust their diets, and apply sunscreen, and I strongly believe that registering to vote should join this list of prescriptions. This simple act can enable patients from every socioeconomic and ethnic background to fight, in a small but absolute manner, for the rights that they believe in. Healthcare and otherwise.

References:

1. McDonald, MP. 2016 November General Election Turnout Rates. United States Election Project. http://ift.tt/1qNsirc accessed November 14, 2016.

2. Gruen RL, Pearson SD, Brennan TA. Physician-Citizens—Public Roles and Professional Obligations. JAMA. 2004; 291: 94-98.       

3. Desilver D, U.S. Voter Turnout Trails Most Developed Countries. Pew Research Center. August 2, 2016. http://ift.tt/2b09bLZ accessed November 14, 2016.

4. Perez V. Representational Bias in the 2012 Electorate. Project Vote. 2015

5. Blakely TA, Kennedy BP, Kawachi I. Socioeconomic Inequality in Voting Participation and Self-Rated Health. Am J Public Health. 2001; 91: 99-104

6. Hill KQ, Leighley JE, Hinton-Andersson A. Lower-Class Mobilization and Policy Linkage in the U.S. States. Am J of Political Science. 1995; 39: 75-86

7. Liggett A, Sharma M, Nakamura Y, Villar R, Selwyn P. Results of a Voter Registration Project at 2 Family Medicine Residency Clinics in the Bronx, New York. Ann Fam Med. 2014; 12: 466-469

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Two Nations Separated by 5.3 mm

By SAURABH JHA MD

 

A popular meme is that the U.S. spends more on healthcare than other developed nations but has nothing to show for that spending. This is different from saying that the U.S. spends more, but achieves something, but the something it achieves is so little that it isn’t worth the public purse. The latter is difficult to assert because the asserter must then say how little is too little in regards to how much is spent, and why. It is easier believing the excess spending has no effect whatsoever, zilch in fact, because this absolves one from having to apply a value judgment on how much a life is worth. This meme, a convenient heuristic, like other convenient heuristics, is wrong.

 

A recent study looked at trends and outcomes in the management of abdominal aortic aneurysm (AAA) in the U.S. and the U.K. An aneurysm, dilation of the aorta, is more likely to burst the bigger it gets. Aneurysms should be repaired before they rupture because the mortality of ruptured aneurysms can be 50 %. The study, which analyzed several databases that recorded surgery, size of aneurysms, and cause of death, found that Americans repair twice as many aneurysms as the Brits, and the repaired AAAs are smaller, on average, in the U.S. Between 2005-2012 elective AAA repair (i.e. repair of non-ruptured aneurysms) increased from 27 to 32 per 100, 000 in the U.K, and from 58 to 64 per 100, 000 in the U.S.

 

Does the increased frequency of repair of AAA in the U.S. reap benefits? It seems so. In 2012, there were twice as many ruptured aneurysms in the U.K. as the U.S., and aneurysm-related deaths were 3.5 times higher in the U.K. Only trends, not absolute numbers, should be inferred from secondary databases. And the trend is clear: in both the U.K. and the U.S., the rates of ruptured AAA and aneurysm-related deaths have declined, while elective AAA repair has increased. The U.K. has reduced aneurysm-related deaths by 20 per 100, 000 by adding only 5 per 100, 000 cases of elective repair. It seems that U.K. has picked the low-lying fruits (large aneurysms) and the U.S. is approaching diminishing returns.

 

 

Roughly, for 32 excess electively repaired AAAs, there are 9 fewer ruptured AAAs and 25 fewer aneurysm-related deaths, per 100, 000. These figures aren’t exact but show that repairing AAA before it ruptures has a good return-on-investment and, as far as life expectancy is concerned, more the merrier. Of note, electively-repaired AAAs have the same outcome – i.e. the same complications and therapeutic effect – in the U.S. and the U.K. Neither the skill of the surgeon, nor the attentiveness of the support staff, seems meaningfully different between the two countries.

 

The corollary of Americans repairing more AAAs is that the size-threshold for repair of AAA in the U.S. is smaller than the U.K. The average size of repaired AAA is 5.8 cm in the U.S. and 6.4 cm in the U.K. At the time of repair of the AAA, on average, is 5.3 mm smaller in the U.S. than U.K. 5.3 mm is a lot! Risk of aneurysm rupture is non-linear – the increased risk of rupture of 65-mm vs. 60-mm aneurysm is more than the increased risk of rupture of 45-mm vs. 40-mm aneurysm, even though the difference in size in the two pairs is the same. The non-linearity of rupture risk means that excess 7-cm AAAs floating around in the U.K, for example, will contribute disproportionately to aneurysm-related mortality.

 

Clearly, the Americans are repairing aneurysms sooner than the Brits and, in many instances, aneurysms smaller than the recommended size threshold. Further, AAA is more likely to be repaired endovascularly – i.e. by a stent – in the U.S. Stents have lower morbidity-mortality than open repair. In the U.S., there are more physicians available to stent AAAs, or more willingness in physicians to stent, or both. Why is this so?

 

Consider an analogy. Peter drinks more alcohol than Paul because he has more alcohol in his house than Paul. But the reason Peter has more alcohol in his house than Paul is because he drinks more alcohol than Paul – he drinks more because he has more and he has more because he drinks more. The process is recursive. Americans stent more because it pays more to stent than not to stent. But crucially, the “more stenting” is not for naught. Americans are more aggressive not only with stenting AAA, but surveillance of AAAs – I can attest to that as I read follow-up CT angiograms for AAA. The “Aneurysm Surveillance Program” puts the vigilance of the Central Intelligence Agency to shame.

 

The study suggests that the size-threshold for repair of AAA, presently 55/ 50 mm (men/ women), should be lower. Thresholds are derived from risk vs. benefit of an intervention – the safer an intervention, the lower the threshold for intervening. Threshold for repair of AAA was derived from a randomized controlled trial (RCT) when aneurysms were repaired by open surgery. Threshold should be revised because now stents, which are safer, are mostly used. The study is an excellent example of how analysis of a secondary database can question practice derived from an outdated RCT.

 

The study also hints that screening for AAAs may be beneficial. However, it won’t be easy for an RCT to show a treatment effect of mass screening for AAA, even though, undoubtedly, some lives will be saved by screening. This is because the outcome, death from ruptured aneurysm, is still an uncommon occurrence, at a population level.

 

In summary, Americans stent more aneurysms and stent smaller aneurysms than the Brits, increasing the longevity of some people with aneurysms. There is another message in this paper. The Americans are repairing aneurysms smaller than the recommended threshold. To state this bluntly – they’re saving lives by ignoring evidence-based medicine (EBM). This is, partly, how medicine progresses – someone ignores the status quo, i.e. guidelines. To advance science you must, occasionally, ignore EBM. This is a paradox until you think about it.

 

This is a good time to deliver my annual message to both countries. Brits: if you want American outcomes, put your money where your mouth is. Americans: if you want British healthcare spending, build more graveyards. Sometimes less is more. Sometimes more is more.

 

About the author

Saurabh Jha is a radiologist and contributing editor to Healthcare Blog. He makes his living measuring aneurysms. He can be reached on Twitter @RogueRad

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American Healthcare Rackets: Monopolies, Oligopolies, Cartels and Kindred Plunderbunds

By NORTIN HADLER, MD

The Healthcare Dollar, the Healthcare Industry and the Healthcare System are shibboleths. All are parlance. All render terms such as Healthcare Profession, Service Profession, and Healthcare Professionals quaint. All drive linguistic determinism: if it’s labeled so, it must be so. Furthermore, all have become jingoistic. This is our dollar, our industry, our system and don’t dare tread on us.

These are shibboleths that engender considerable cognitive dissonance. If healthcare is no longer a service profession but an industry that transfers wealth in a systematic fashion, shouldn’t it comply with the legal constraints that tightly govern other industries including others that serve essential needs of the population?

For many such industries the states have an important degree of control over productivity and pricing. Insurance Commissions provide governance over the cost and scope of companies purveying homeowner’s, automobile and Workers’ Compensation insurance. Utility Commissions regulate the rates and services of private sector public utilities. Boards of Education perform similarly whether education is public or private. Federal statutes complement the states’ role in consumer protection. For example, attempts to construct monopolies are met with regulatory zeal.  Otherwise communication and energy monopolies would never have been “busted” and unconscionable pricing would be rampant. This form of check-and-balance relies on the consumers’ political leverage when they realize they are being ripped off.

The track record is far from perfect. Take the “military-industrial complex” (please), an industry charged with supplying armaments and whatever else is needed to support the proclivity of our species to seek violent solutions to disputes and violent means to assuage insatiable greediness. Historically, this was a cottage industry populated by craftsmen, farmers, and all manner of factotums. This cottage industry, like nearly all others, did not survive the industrial revolution. Thanks to unbridled growth in demand and in ingenuity a behemoth has superseded.  In FY 2017, total US government spending for defense (including military defense, veterans’ affairs, and foreign policy) is budgeted to be $853.6 billion, with ¾ for “defense.” This has represents about 5% of the GDP annually during the War on Terror. The expenditure was about 40% of the GDP during World War II and settles down near 1-2% between wars. The military-industrial complex is largely an oligopoly since very few companies are in the modern armaments business, or the business of providing supportive services for that matter. It is a peculiar empire with many an idiosyncrasy, including many that are tolerated despite ethical compromises. For example, the Pentagon typically contracts for goods and services on a “cost-plus” basis resulting in delays and overruns which may lead to penalties and subsequently to more costly contracts that factor in the penalties and promote recidivism. Many an advance in weaponry is initiated by the private sector in collaboration with government and military professionals. We are all aware of the notion of the “revolving door” which predisposes to bread buttering even if the butter must remain in cold storage for a regulated interval. We are all aware of abuses in pricing, such as the infamous air force ashtrays. We are all aware of “this dog won’t hunt” disappointments moldering somewhere without penalty for the manufacturers. We are all aware that the denizens of K Street include a great number of lobbyists for the military-industrial complex. These lobbyists have many agendas, not the least of which is to participate in the debates that define allies who are an appropriate primary or secondary market for armaments. We are also aware of the lobbyists whose agenda is domestic sales. We are awash in claims of our military’s ascendency based on incontrovertible outcome measures in the details of the violence that is wreaked and the intensity of the racket made by our rattling sabers. We are variously amazed and bemused by the mind-boggling transfer of wealth necessary to create corpses. It’s all business as usual. It’s all assumed or asserted to be a necessary evil. And it’s so well-funded and established that cries for reform are largely lost in the din of routine.

It’s so familiar a scenario that we can find it reasonable for the Healthcare Industry to operate on a similarly organized playing field. Before I detail the parallels, let me emphasize that I am not unleashing a diatribe against the players. I am targeting the playing field. I am also not writing a partisan screed. The playing field I decry is the home turf today for fee-for-service, ACA, single payer, block grant, and other reform advocates.

I do not excuse the players for the errors of their ways, but blaming them misses the forest for the trees. Many, if not most, of the leading players in the healthcare and military-industrial complexes are competent, well-meaning and doing the best they can. For example, most military leaders were the fine youngsters admitted to our service academies where they are imbued with traditions of honor and patriotism. The precedent for training leaders in medicine is more of a moving target. Unlike the military, healthcare survived the industrial revolution as a cottage industry and its practitioners as a guild well into the 20^th C before it transitioned to “industry” statues. Nonetheless, most students enter medical school today brimming with talent and with sincerely held goals regarding the betterment of mankind. American medical schools are less likely to foster these goals than the service academies. The goals of the industry insinuate earlier. The unanticipated consequences of this insinuation become apparent in postgraduate life. That’s when the young doctor is disabused of any residual notion that the patient’s care and the people’s wellbeing are principle raisons d’être of the Healthcare Industry. These young practitioners have crossed the Rubicon and now their resilience is to be tested.

Connivance and Collusion

So much of what is reprehensible about American healthcare has been comprehensively documented by many authors – including me in the context of my writing to empower patients to ask telling questions. Here I will emphasize the enabling economic and organizational structures that would not be tolerated in a service profession but are well entrenched in the Healthcare System.

Foremost is rampant Regulatory Capture. The Nobel Prize winning economist, George Stigler, was one of the luminaries in the mid-century “Chicago School”. Stigler developed a theory of economic regulation by analyzing the positive and negative influences of public power on the economic status of industries and occupations. Regulatory capture recognizes the tendency for a regulatory agency, created to act in the public interest, to be dominated by the interests it was meant to regulate. In the Healthcare System captured agencies are seldom furtive; rather the capture is declared expedient if not necessary.

The FDA is our object lesson. The current director was appointed despite considerable misgivings relating to his career as a drug “trialist”, including his prior role as director of Duke’s Clinical Research Institute (CRI), a Clinical Research Organization (CRO.) He denies being on the payroll of any pharmaceutical entity although his compensation at Duke was noteworthy and the CRI itself brought Duke a pretty penny (in a law firm he’d be called a “rainmaker”). His predecessor at the FDA departed under something of a cloud relating to conflictual relationships between her husband’s financial firm and particular pharmaceutical firms. All this is innuendo at least, certainly unseemly, but it pales next to the institutionalized conflictual relationships that exist between the FDA and the pharmaceutical industry. Several are statutory or officially sanctioned. A substantial portion of the FDA’s budget is derived from users’ fees, income collected from the petitioning company as the price for determining whether any New Drug Application merits licensure. This tithe alone renders the relationship between the FDA and its clients unhealthy. The political climate keeps them in bed together; there are 6 healthcare lobbyists available to “help” each member of congress appreciate the value of the pharmaceutical industry and of its omnipresent advocacy organization, PHrMa. PHrMa is a behemoth on K Street shelling out far more largesse in 2012 than the lobbyists for the military-industrial complex and big oil combined. Of course, this budget is skimmed off the top of the cost of drugs, devices and potions.

There are other aspects of the licensure process for new drugs that should cause widespread discomfort and debate. Very few of the licensed new drugs are really “new” let alone major therapeutic triumphs. Most are either “me too” agents or afford very few patients more than very little benefit. On top of that, the rare drug that is really a breakthrough is a nearly always a triumph of academic investigators funded by federal dollars; the pharmaceutical firms co-opt the federally funded intellectual property, often gratis, and patent the therapeutic derivative. These are the hard realities of an industry that has largely overgrown its usefulness but not its avarice. And the avarice is facilitated by naiveté on the part of society and inadequacies of oversight. I can find little in the history of the pharmaceutical industry that speaks to originality in its business model, only exploitation. The industry backed onto its perch as an inviolate cash cow. One secret to this evolution is my friend and former colleague, the brilliant biostatistician Dennis Gillings. We were junior faculty together, co-authoring papers and co-editing a book in the 1970s, when Dennis discovered another personal skill and proclivity. Dennis was willing to consult with the pharmaceutical industry regarding the development of drug trials and the presentation of the forthcoming data in a fashion that satisfied the requirements for licensing new drugs or licensing old drugs for different indications. That proclivity became Quintiles Transnational and then the entire CRO industry. I have a great deal of respect and warmth for my Horatio Alger friend but no respect for the industry he spawned and the consequences of its success. Without CROs, I can’t imagine that total prescription drug spending would have exceeded $450 billion (16.7 percent of health care spending) by 2015 or be estimated to increase annually by 6.7 percent through 2025.

Here’s how the shell game works. CROs are the go-to for pharmaceutical firms when they are ready to subject a drug to a licensing trial. Since they anticipate that the drug will have little efficacy at best, affording slight benefit to most or more benefit to very few, the licensing trials are expensive, large, and sloppy (it’s hard to find appropriate subjects, harder to recruit them, and hardest yet to maintain adherence to the trial’s methodology.) CRO’s are contracted at great cost to undertake this exercise. If this was elegant science, equipoise would dominate the methodology, i.e. no one would have any preconception regarding the outcome. However, this is a business arrangement that inherently lacks equipoise: the drug company anticipates success and the CRO has reason to see their client emerge pleased with their contracting. Large sloppy trials seeking small effects lend themselves to all sorts of data massaging and data torturing in the subliminal (or not) quest for success. No wonder these trials are far more likely to demonstrate a statistically significant degree of efficacy if undertaken by a CRO than when the same drug is studied by trialists with federal funding.

So, the applications for the licensure of new drugs that appear in the FDA’s in-box, wrapped in user fees, are seldom overwhelmingly compelling. They tend to support the assertion that there is a statistically significant difference in efficacy between the active drug and the comparator although the magnitude of difference is debatable in terms of clinical meaningfulness. The FDA is not unaware of this “subtlety”. It convenes advisory panels of experts with relevant experience and often relevant conflictual relationships, which Congress deemed acceptable. Interestingly, when studied these experts are not predisposed to look kindly on drugs produced by companies for which they are paid consultants; rather, they are predisposed to disparage the competition. So me-too and small effect drugs are routinely licensed and heavily marketed with language often designed to mislead. For example, how often do we hear that some agent offers a 50% reduction in some outcome when we should have been told that if 400 patients took the drug for 6 months, only one would suffer an untoward outcome compared to 2 who didn’t take the drug (e.g. AstraZeneca’s Jupiter trial which turned Crestor into a “blockbuster” drug ). This is a ploy that plays out at great expense only in America. Direct-to-consumer advertising is not countenanced in any other country save New Zealand where the approach is, comparatively, very understated.

All this is business as usual, and I am not the sole critic. Recently, the FDA and CMS (Medicare Administration) have decided to collaborate regarding the clinical utility of the licensed interventions afforded the Medicare population, a collaboration offered with considerable sanctimony as if this is a novel agenda. It isn’t; it ignores precedents such as PCORI in the ACA, the clinical guidelines kerfuffle, and the machinations of the National Quality Forum (NQF) and the Institute for Healthcare Improvement (IHI). The NQF and the IHI started as advocacy groups that have grown into sizable organizations that capture many millions of dollars to push their agenda. For example, the NQF receives over $10 million annually from CMS (Medicare) to provide the performance measures CMS uses to monitor the quality of the services it purchases. NQF is still reeling from scandals. The first caused the dismissal of its Chair, Dr. Charles Denham, after the Department of Justice accused him of profiteering from kickbacks to the tune of $11.6 million. He was replaced by Dr. Christine Cassel, recruited in 2012 from the American Board of Internal Medicine (ABIM) which she had chaired for a decade. Her appointment to NQF raised a cloud of dust when it was learned that she was paid nearly a quarter of a million dollars by Premier, Inc., a Charlotte, North Carolina company that offers group purchasing and performance improvement consulting for nearly 3000 hospitals and thousands of nursing facilities. Premier clearly has a stake in the work of the NQF and Cassel has since seen wisdom in discontinuing her relationship with this and other similar entities.

The FDA is the object lesson I’ve focused on. But there is a wealth of object lessons all with their distinctive acronym: ACGME, ABIM, AHA, ABMS, ACS, CMS (MIPS, MACRA), HIPAA and there are many more in the alphabet soup. Others are known by their full name like The Joint Commission, a non-governmental agency that wields accreditation with power and authority causing some 20,000 health organization, particularly hospitals, to cringe and comply.  Acronym or not, all these bearers of standards beg critical analysis. All have regulatory influence and all have fallen victim to regulatory capture to some degree. Too often it’s to a degree that undermines benefits to be derived from adherence to standards and regulations. The overlapping of purview and the ubiquity of regulatory capture has created a regulatory establishment that requires ever more funding to support its unbridled reach. It has a life of its own which increasingly impedes the recognition of and response to the needs of the person who has turned to a physician for solace, support, wisdom and care. The American Healthcare Industry desperately needs to be healed of this affliction so that it can provide the infrastructure for America’s Service Professionals to practice according to their conscience and for America’s patients to be served with the uncompromised elegance that has finally become possible in the 21^st C. The promotion and growth of a Healthcare Industry is social iatrogenesis at its worst.

Nortin Hadler emeritus professor of medicine and microbiology/immunology at the University of North Carolina, is the author of Worried Sick, Rethinking Aging, Citizen Patient, and By the Bedside of the Patient. 

from THCB http://ift.tt/2go4AIu